An appropriate infrastructure or quality system encompassing the Procedures, Processes, Resources

The systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for Quality

The totality of these actions is termed Quality Assurance

4Quality Management

Terminology may differ

Quality System is said to be rarely used in drug manufacturing

The concepts of QA, GMP QC are interrelated aspects of Quality Management.

They are described on the following slides in order to emphasize their relationship their fundamental importance to the production control of pharmaceutical products

5Principles of QA

Wide-ranging concept

covers all matters that individually or collectively influence the quality of a product

Totality of the arrangements

to ensure that the drug is of the right quality for the intended use

QA incorporates GMP

And also product design development which is outside the scope of this module

6Requirements for QA Systems

1. Ensure products are developed correctly

2. Identify managerial responsibilities

3. Provide SOPs for production control

4. Organize supply use of correct starting materials

5. Define controls for all stages of manufacture packaging

7Continue

6. Ensure finished product correctly processed checked before release

7. Ensure products are released after review by authorized person

8. Provide storage distribution

9. Organize self-inspection

8GMP

Ensure that products are consistently produced controlled

Diminishes risks that cannot be controlled by testing of product

Cross-contamination

Mix-ups

9Basic Requirements for GMP

1. Clearly defined systematically reviewed processes

2. Critical steps validated

3. Appropriate resources personnel, buildings, equipment, materials

4. Clearly written procedures

5. Trained operators

10Continue

6. Complete records, failure investigations

7. Proper storage distribution

8. Recall system

9. Complaint handling

11Quality Management

Quality relationships

Quality Management

QA

GMP

QC

12Quality Management

QC

QC is part of GMP

13QC Department

Each holder of a manufacturing authorization should have a QC Department

Independence from production other departments.

Under the authority of an appropriately qualified experienced person with one or several control laboratories at his or her disposal.

14Basic Requirements for QC

Resources

Adequate facilities

Trained personnel

Approved procedures

15Basic Requirements for QC

Tasks

Sampling

Inspecting

Testing

Monitoring

Releasing/rejecting

16Basic Requirements for QC

Objects

Starting materials

Packaging materials

Intermediates

Bulk products

Finished products

Environmental conditions

17Basic Requirements for QC

1. Sampling approved by QC department

2. Validated test methods

3. Records

4. Review evaluation of production documentation

5. Failure investigations for all deviations

6. Ingredients comply with the marketing authorization

18Continue

7. Ingredients are of the required purity

8. Proper containers

9. Correct labelling

10. Release of batches by the authorized person

11. Retained samples of starting materials

products

19Other Duties of the QC Department

1. Establish QC procedures

2. Reference standards

3. Correct labelling

4. Stability testing

5. Complaint investigations

6. Environmental monitoring

20

Assessment of Finished Products

Should embrace all relevant factors. Example

Production conditions

In-process test results

Manufacturing documentation

Compliance with finished product specification

Examination of the finished pack

21QC Access

QC personnel must have access to production areas for sampling investigation

Appropriately!

22Summary

QC is part of GMP

Sampling

Specifications

Testing

Release procedures

Recalls Complaints

Decision-making in all

quality matters

23Reference

Basic Principles of GMP /module/ WHO-EDM

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